Regulatory Strategy Development

Our team is ready to help you determine the appropriate regulatory strategy in order to get your device on the market as efficiently as possible. We are experienced in working with the FDA and understand the complex processes that can be involved in marketing medical devices and acquiring FDA approval.

We can work with your company to align business goals with regulatory goals in order to determine the best strategy for FDA marketing indications. We are ready to review existing data in order to help determine additional testing and realistic timelines in ensure success with the FDA. Our strategy development will be specifically tailored to your goals and we will work closely with your business stakeholders to ensure that all your regulatory needs are met.

Device Classification and Intended Use Development

An important step in the regulatory consulting process is determining device classification in order to appropriately identify the primary FDA advisory committees. Determining device classification can help ensure that the correct regulatory submissions are being completed in order to streamline the approval process. This process may involve submitting a 513(g) classification request, in which our team is highly experienced. Learn more about device classification.

Along with device classification, developing the appropriate intended use for a device is key to efficient FDA approvals. Intended use development often requires extensive clinical research to navigate the appropriate language. Our team can assist with research and consulting with experts in order to identify an indication for use statement that will lead to a successful marketing strategy. Learn more about intended use.

Digital Health and SAMD

Development of Testing Plans

We help companies develop testing protocols and find appropriate testing facilities. We have built relationships with a variety of testing experts that can help with the following:

• Development of bench testing plans
• Biocompatibility testing protocol review
• Pre-clinical/animal study protocol development and review
• Clinical study design
• Clinical trial statistical planning
• Software validation protocol review
• Human factors testing design and report reviews
• Review of applicable standards
• Development of literature review summary

Regulatory Submission Preparation

We can assist with a number of FDA regulatory applications, including the preparation of clinical study and marketing submissions. In some cases, resubmissions may need to be completed when there are significant product or labeling changes. We can assist in determining the need for resubmissions and help with the resubmission efforts. Some of the applications we can help with include:

• 513(g) Device Classification
  • As previously discussed, device classification is an important step in ensuring that the appropriate regulatory submissions are being prepared and submitted. Our team is experienced in device classifications procedures and can help with this process.
  • Learn more about 513(g)s
• Premarket Notifications or 510(k)
  • Premarket notifications are used to inform the FDA that your device is equivalent to a device already on the market. This is required for commercial distribution of new devices or existing devices that have been significantly modified.
  • Learn more about 510(k)s
• Investigational Device Exemption (IDE):
  • IDEs allow an investigational device to be used in a clinical study to collect safety and effectiveness data. These require an IRB-approved investigational plan, informed consent from all patients, investigational use only labeling, monitoring, records, and reports. This process can be time-consuming and tedious, but our detail-oriented team can help to construct a successful IDE application.
  • Learn more about IDEs
• Premarket Approval (PMA)
  • PMAs are used to review the effectiveness and safety of class III medical devices. This is required for class III devices prior to marketing a device and is one of the most rigorous FDA applications. PMA applications typically take several years to complete and our team can help navigate you through the process including design, quality, and manufacturing reviews.
  • Learn more about PMAs
• Emergency Use Authorization (EUA)
  • EUAs are used to allow unapproved medical products or unapproved use of medical products in cases of emergency against health threats.
  • Learn more about EUAs

Post-Market Surveillance

After a device is approved, follow-up clinical or marketing protocols may need to be created in accordance with FDA commitments. Our team can help determine all post-market requirements and timelines for continuing assessments.